Clinical Trials

Numerous clinical trials evaluate pirarubicin from Early Phase 1 through Phase 4, primarily focusing on oncological malignancies—such as breast cancer, osteosarcoma, prostate cancer, pediatric nephroblastoma, and non-muscle invasive bladder cancer—alongside secondary conditions including depression. Sponsored largely by academic medical centers and university networks, such as the Dana-Farber Cancer Institute, Shengjing Hospital, and Peking University People's Hospital, these studies encompass recruitment statuses ranging from completed and active non-recruiting to actively recruiting and not yet recruiting, reflecting sustained clinical interest in pirarubicin regimens.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07424287 RECRUITING
NMIBC
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
 2026-07-13 PHASE3
NCT05287308 NOT_YET_RECRUITING
Breast Cancer
Chinese Academy of Medical Sciences
 2022-03
NCT07178171 RECRUITING
TNBC, Triple Negative Breast Cancer
Xijing Hospital
 2025-11-06 PHASE1
NCT04437160 RECRUITING
Triple Negative Breast Cancer
Chinese Academy of Medical Sciences
 2020-02-01 PHASE2
NCT06714383 RECRUITING
Osteosarcoma
Peking University People's Hospital
 2024-11-13 PHASE2
NCT02923557 UNKNOWN
Bladder Recurrence; Upper Tract Urothelial Carcinoma; Nephroureterectomy
Peking University First Hospital
 2016-11 PHASE2
NCT05099341 Recruiting
Depression
Centre Hospitalier Universitaire Dijon
 2021-10-01 Not Applicable
NCT02740426 UNKNOWN
Upper Tract Urothelial Carcinoma; Bladder Recurrence
Peking University First Hospital
 2016-08 PHASE2
NCT03892330 NOT_YET_RECRUITING
0.5-14 Year Old Children With Nephroblastoma
Shengjing Hospital
 2019-06-01 PHASE4
NCT02547350 UNKNOWN
Upper Tract Urothelial Carcinoma; Bladder Recurrence
Xuesong Li
 2015-09 PHASE2
NCT03342300 WITHDRAWN
Progression-free Survival; Overall Survival; Toxicity
Peking University People's Hospital
 2017-11-06 PHASE2; PHASE3
NCT03030157 UNKNOWN
Intravesical Instillation
RenJi Hospital
 2017-01 PHASE2
NCT04126811 UNKNOWN
Soft Tissue Sarcoma
Tianjin Medical University Cancer Institute and Hospital
 2019-06-01 PHASE2
NCT04158817 Completed
Prostate Cancer
Shanghai General Hospital Shanghai Jiao Tong University School of Medicine|NanoMab Technology (UK) Limited
 2019-11-01 Early Phase 1
NCT03716180 Active not recruiting
Breast Cancer
Dana-Farber Cancer Institute|Susan G. Komen Breast Cancer Foundation|Breast Cancer Research Foundation|Terri Brodeur Breast Cancer Foundation
 2018-11-05 Phase 1
NCT02301091 UNKNOWN
Hepatocellular Carcinoma
Ming Zhao
 2014-10 PHASE3
NCT02903524 UNKNOWN
Breast Cancer
Hebei Medical University Fourth Hospital
 2016-09 PHASE4
NCT01746992 UNKNOWN
ALK-negative Anaplastic Large Cell Lymphoma; Peripherial T Cell Lymphoma,Not Otherwise Specified; Angioimmunoblastic T Cell Lymphoma; Enteropathy Associated T Cell Lymphoma; Hepatosplenic T Cell Lymphoma; Subcutaneous Panniculitis Like T Cell Lymphoma
Ruijin Hospital
 2012-09 PHASE4
NCT02585479 WITHDRAWN
Hepatocellular Carcinoma
Guangxi Medical University
 2015-10 PHASE2; PHASE3
NCT02755311 UNKNOWN
Hepatocellular Carcinoma
Sun Yat-sen University
 2014-03 PHASE3
NCT02838225 COMPLETED
Breast Cancer
Peking Union Medical College Hospital
 2009-01 PHASE2
NCT02613026 COMPLETED
Breast Neoplasms
307 Hospital of PLA
 2009-07 PHASE3
NCT01249690 UNKNOWN
Multiple Myeloma
Second Military Medical University
 2010-06 PHASE4
NCT00131053 UNKNOWN
Lymphoblastic Leukemia, Acute
Japan Adult Leukemia Study Group
 2002-09 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-20)

Check the Pirarubicin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pirarubicin intercalates into genomic DNA and inhibits topoisomerase II, disrupting essential DNA replication and RNA transcription pathways to trigger apoptotic cell death. By blocking cell proliferation through this mechanism, pirarubicin exerts potent antineoplastic effects relevant to clinical trial evaluations in breast cancer, osteosarcoma, and urothelial malignancies.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.